BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1913913 · Received November 30, 2010

    Report

    Report Number
    3006630150-2010-01958
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MFG DOCUMENTATION FOR THE IPG AND PADDLE LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MFG. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE IPG AND PADDLE LEAD FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WAS EXPLANTED DUE TO INFECTION AT THE POCKET SITE. THE PT'S SYMPTOMS INCLUDED GREEN OOZING PUS AT THE IPG SITE. THE PT WAS GIVEN ORAL ANTIBIOTICS AND WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention MODEL# SC-8116-50, SERIAL # (B)(4)| ARTISAN 2X8 PADDLE LEAD, 50CM: